A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
NCT ID: NCT03842761
Last Updated: 2021-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2019-03-06
2021-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose group 1
Low Dose
BI 685509
Tablet
Placebo
Tablet
Dose group 2
Medium Dose
BI 685509
Tablet
Placebo
Tablet
Dose group 3
High Dose
BI 685509
Tablet
Placebo
Tablet
Dose Group 4
Dose for healthy volunteers dependent on results from prior dose groups with patients
BI 685509
Tablet
Placebo
Tablet
Interventions
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BI 685509
Tablet
Placebo
Tablet
Eligibility Criteria
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Inclusion Criteria
* Male or female. Women of childbearing potential (WOCBP) participants and male participants able to father a child must be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly throughout the Trial
* Mean Arterial Pressure (MAP) ≥ 85 mmHg at screening visit
* Estimated Glomerular Filtration rate (eGFR) \> 70 mL/min/1.73m² according to the CKD-EPI formula at screening visit
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Key inclusion for Patient Groups 1 and 2
* If on treatment with non-selective beta blockers (NSBB), stable dose since ≥ 8 weeks prior to screening, with no planned dose change of the therapy during study conduct. All other medications stable 4 weeks prior to screening.
* Patient Group 1: Patients with CTP A and portal hypertension (defined as liver stiffness \>15 kPa during screening) and without a previous decompensation event \[ascites, variceal hemorrhage, encephalopathy, or jaundice (except Gilbert's disease or hemolysis when bilirubin will be almost exclusively indirect hyperbilirubinemia)\]. Self-limited and resolved historical events of decompensation like ascites or encephalopathy are allowed if they have occurred at least 6 weeks prior to screening and do not require continued therapeutic intervention at the time of screening.
* Patient Group 2: Patients with CTP B (with liver stiffness \>15 kPa during screening)
Key inclusion for Healthy Volunteer group
* Subjects who are healthy, according to the investigator's assessment, individually matched to a participant among Patient Groups 1 and 2 according to the following criteria: age within ± 5 years, body weight within ± 15%, and gender
Key exclusion for all trial participants
* Ongoing chronic alcohol or drug use, which in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
* History of relevant orthostatic hypotension, fainting spells, or blackouts based on the investigator´s judgment
Key exclusion for Patient Groups
* Patient Group 2: treatment-refractory ascites
* Patient Group 2: recent decompensation event (refractory ascites, recurrent variceal hemorrhage, recurrent hepatic encephalopathy, spontaneous bacterial peritonitis or hepatorenal syndrome) within 6 weeks of screening
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Countries
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Related Links
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Related Info
Other Identifiers
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1366-0020
Identifier Type: -
Identifier Source: org_study_id
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